Agenus Begins Dosing with Next-Gen Anti-CTLA-4 Antibody

LEXINGTON, Mass., April 2, 2019 /PRNewswire/ -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune-modulating antibodies, cancer vaccines, adjuvants and adoptive cell therapies1, today announced that the first patient was dosed in the clinical trial of its next-generation anti-CTLA-4 antibody (AGEN1181). AGEN1181, a novel 'Fc engineered' antibody with potential for enhanced anti-tumor functions, is specifically designed to boost cancer killing immune cells and deplete cells that block the activity of these cancer killing cells.

The first patient in the trial was dosed by Dr. Steven J. O'Day, M.D., Executive Director of the John Wayne Cancer Institute & Cancer Clinic, and a pioneer in delivering immune therapies to patients with cancer. Dr. O'Day's pivotal work has led to the approvals of commercial antibodies targeting CTLA-4 and PD-1. "AGEN1181 represents an important next-generation breakthrough with its potential for enhanced immune activation and tumor fighting abilities," said Dr. O'Day. "The pre-clinical data so far suggest that AGEN1181 may bring superior benefit compared to first generation anti-CTLA-4 antibodies and may be an optimal partner for combinations. I am thrilled to be working with this compound."

"AGEN1181 is a product of Agenus' innovation engine that has been key to rapidly delivering new discoveries to patients," said Garo Armen, Ph.D., Chairman and CEO of Agenus. "AGEN1181 was developed based on a new mechanism of action discovered by our scientists. In addition to this monotherapy trial, we plan to pursue combination studies with AGEN1181 soon. Besides AGEN1181, additional important discoveries from our innovation engine are also advancing towards the clinic this year."

The Phase 1, open-label, multicenter study is designed to assess the maximum tolerated dose of AGEN1181 in subjects with advanced solid tumors. It will also evaluate the safety, tolerability, PK, and PD profiles and immunogenicity of this antibody. The outcome will determine the recommended phase II dose of AGEN1181.

AGEN1181 was developed based on a discovery made by Agenus scientists, that involves modification of a key region of an antibody, known as the "Fc region", to design next-generation, 'Fc engineered' antibodies that may significantly enhance functionality and antitumor immunity. To learn more about AGEN1181 and its potential advantages over first-generation anti-CTLA-4 antibodies, please see Agenus' Newsletter here.

About AgenusAgenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body's immune system to fight cancer. The Company's vision is to expand the patient populations benefiting from cancer immunotherapy by pursuing combination approaches that leverage a broad repertoire of antibody therapeutics, proprietary cancer vaccine platforms, and adoptive cell therapies (through its AgenTus Therapeutics subsidiary). The Company is equipped with a suite of antibody discovery platforms and a state-of-the-art GMP manufacturing facility with the capacity to support early phase clinical programs. Agenus is headquartered in Lexington, MA. For more information, please visit www.agenusbio.com and our twitter handle @agenus_bio. Information that may be important to investors will be routinely posted on our website and twitter.

Forward-Looking Statements

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding: the clinical utility of AGEN1181; expectations regarding the results of the Phase 1 study of AGEN1181; expectations for future clinical trial plans and development activities of AGEN1181; our clinical trial plans and activities, research and development plan and activities for antibodies other than AGEN1181; and the anticipated operations and benefits of AGEN1181 and our other programs. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Quarterly Report on Form 10-Q or Annual Report on Form 10-K filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.